A multicenter randomized controlled trial comparing long term scar quality after hydrosurgical versus conventional tangential excision of deep dermal burns

Completed

• Conditions: Burn injury; 10022114; 10040795

• Registration Number: NL-OMON43015
• Lead Sponsor: Maasstad ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 137

Inclusion Criteria

Deep dermal burns of at least 50cm2 who require primary excision and grafting.

Exclusion Criteria

- No operation indication
- TBSA < 50cm2
- TBSA > 30%
- Full thickness burns
- Chemical or electrical burns
- Infected wounds
- No informed consent
- Patients that are unlikely to comply with requirement of the study protocol and follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is scar quality assessed as the POSAS (Patient and<br /><br>Observer Scar Assessment Scale) Observer Score at 12 months post-burn scored by<br /><br>2 blinded observers independently. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In addition we compare dermal preservation after the two different kinds of<br /><br>surgery and calculate the Minimal Important Change of the POSAS. This is the<br /><br>minimal difference in scar quality that patients experience as important.</p><br>